GUEST COLUMNISTS

• Financial Market Tumult Shows The Need For Creative Funding For Life Sciences

  Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?

• Mold Investigations Using Biofluorescent Particle Counting Systems

  In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime. 

• FDA Updates Guidance For Investigating OOS Test Results

  FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.

• Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem

  I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.

• Unlocking New Insights And Treatments For Genetic Eye Diseases: ADOA

  This article explores how ADOA (Autosomal Dominant Optic Atrophy) occurs, and why it has become a promising target for new approaches to treatment.

• FDA Proposes Benefit-Risk Considerations For Product Quality Assessments

  The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.

• How To Navigate Drug Repurposing And Bridging Studies

  Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

• How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery

  With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.